Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2530138

FEI Number

1000221205

Entity Name

XODUS MEDICAL, INC.

City/State/Country

New Kensington, PA, US

Establishment Address

702 PROMINENCE DR., New Kensington, PA 15068, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

XODUS MEDICAL, INC. (Owner Number: 9010904)

Owner / Operator Contact Address

702 PROMINENCE DR., --, New Kensington, PA 15068, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Pre-printed Labels See Sharp Correct Site Skin Markers Skin Markers Grounding Pad Tube Holders Suction Tips, Tubing and Connectors Safety Scalpel Non-Surgical Isolation Gown Sponge Counter Bags Sponge Counter Rack Foot Pedal Bag Elastic Band Wrap Electrosurgical Pencils Electrosurgical Tips Foam Pouch Instrument Protectors Various Suture Bags Tray Corner Protectors NTI- Nasotracheal Tube Immobilizer Trocar Cleaner XL Trocar Cleaner Surgical Scalpel Blades Emesis Bags Emesis Bag Dispenser Bowls Basins Asepto Syringe X-ray Detectable Sponges & Gauze Anti-fog with Pad Various Trays Transfer Zones SCALPEL HOLDER Medication cups, bowls & basins O.R. Towels & Sponges Absorbent and Antifatigue Mats Stretcher Pads Cautery Tip Cleaner Face Protection Shield ArthroSleeve Shoulder Arthroscopy Kit Shoulder Suspension Kits EZ Kits OR Turnover Kits SutureSafe Syringe Transfer Cup Safety Stop Scalpel Holder Blue Safety Foam Block Needle Counters Sponge Counter Bag

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LYV	Label Or Tag, Sterile	General, Plastic Surgery	Class 1	878.4800	2005-12-15
OCT	Anti Fog Solution And Accessories, Endoscopy	Gastroenterology, Urology	Class 2	876.1500	2019-06-17
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2019-06-17
FZZ	Marker, Skin	General, Plastic Surgery	Class 1	878.4660	2005-10-04
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2021-02-04
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2006-02-13
JOL	Catheter And Tip, Suction	General Hospital	Class 2	880.6740	2008-10-02
GDZ	Handle, Scalpel	General, Plastic Surgery	Class 1	878.4800	2009-06-05
OEA	Non-Surgical Gown	General, Plastic Surgery	Class 1	878.4040	2020-05-04
FWZ	Operating Room Accessories Table Tray	General, Plastic Surgery	Class 1	878.4950	2007-05-18
FQM	Bandage, Elastic	General Hospital	Class 1	880.5075	2013-04-15
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2008-10-02
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2010-04-02
GES	Blade, Scalpel	General, Plastic Surgery	Class 1	878.4800	2008-10-02
FNY	Basin, Emesis	General Hospital	Class 1	880.6730	2006-02-13
KYZ	Syringe, Irrigating (Non Dental)	General Hospital	Class 1	880.6960	2008-10-02
GDY	Gauze/Sponge, Internal, X-Ray Detectable	General, Plastic Surgery	Class 1	878.4450	2008-10-02
OCT	Anti Fog Solution And Accessories, Endoscopy	Gastroenterology, Urology	Class 2	876.1500	2007-03-06
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2005-10-04
KYW	Container, Liquid Medication, Graduated	General Hospital	Class 1	880.6430	2008-10-02
FRL	Fiber, Medical, Absorbent	General Hospital	Class 1	880.5300	2008-10-02
FPP	Stretcher, Hand-Carried	General Hospital	Class 1	880.6900	2005-12-15
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2006-02-17
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2020-05-04
KQZ	Component, Traction, Non-Invasive	Orthopedic	Class 1	888.5890	2007-11-06
KDD	Kit, Surgical Instrument, Disposable	General, Plastic Surgery	Class 1	878.4800	2005-12-15
GAB	Needle, Suturing, Disposable	General, Plastic Surgery	Class 1	878.4800	2001-05-31
FQA	Scale, Surgical Sponge	General Hospital	Class 1	880.2740	2017-07-13

Official Correspondent

Paul Lloyd

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

XODUS MEDICAL, INC.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K914997	Conmedcorp	ASP-IRRATOR	1992-01-07
K153773	Olympus Medical Systems Corp.	Disposal Lens Cleaning Sheath	2016-11-22
K940141	Micro-Medical Devices, Inc.	LAPARAOSCOPES ELECTRONIC WITH STERILE SHEATH	1994-05-19
K933812	Advanced Surgical, Inc.	ADVANCED SURGICAL, INC. CANNULA CLEANING DEVICE AND ACCESSORIES	1993-12-13
K254228	Karl Storz SE & CO. KG	KARL STORZ Trocars with Valve Seals	2026-05-11

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0027-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Lap Banding Kit, REF: K0398 Contains: (2) C0Q04, 5x100mm Threaded Kii Access System (1) C0604, 15x100mm Non-Threaded Separator System w/Universal Seal, for laparoscopic procedures.
Z-0028-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Lap Banding Kit, REF: K0406 Contains: (1) C0658, 11x100mm Threaded Shielded Trocar w/Universal Seal (1) C0522, 5x100mm Threaded Premium Flat Blade (1) C2202, 150mm Insufflation needle (1) C0605, 15x100mm Threaded Separator Access System (1) CB030, 5mm x 35cm Direct Drive Disposable Scissors (2) C4120, 5mm x 38cm Direct Drive Grasper Reposable Cartridge, for laparoscopic procedures.
Z-0029-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Lap Roux-EN-Y Kit, REF: K2129 Contains: (1) C0Q04, 5x100mm Threaded Kii Access System (1) C0130, 12x100mm Optical Separator System, Non-handled (2) C0Q10, 5x100mm Threaded Kii Cannula and Seal (1) C0605, 15mmx100mm Threaded Cannula System, for laparoscopic procedures.
Z-0031-06	Rita Medical Systems	2	Rita Brand Habib 4X Electrosurgical Coagulator, Catalog Number: 4401US; Product is distributed by RITA Medical Systems, Inc., One Horizon Way. Manchester, GA 32826
Z-0007-2013	Invuity, Inc.	2	BriteField illuminated Suction Device; Model numbers 8Fr, 10Fr and 12Fr, Kit (included 8Fr, 10Fr and 12Fr and a sterilization tray. The Invuity Brite Field Illuminated Suction Device is intended to aspirate from the surgical site and to provide illumination from a high intensity light source.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2530138. Last updated year: 2026. Please use registration number 2530138 when referencing this establishment in official correspondence.